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Kobold® Prostate HDR Template - 18 ga
FDA UDIClass II (US FDA UDI)
by Kobold, Llc
Identity
- Trade Name
- Kobold® Prostate HDR Template - 18 ga FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Labelled with CE FDA UDI
- Model / Reference
- 804-000 FDA UDI
- Description
- Labelled with CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815568021240 FDA UDI
- 510(k) Number
- K170203 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Needle guide, single-use
Kobold® Prostate HDR Template - 18 ga by Kobold, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
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- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Cleared under the same submission
K170203 also covers:
- Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Stepper Template - 6 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Template - 16 ga/5 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Template - 16 ga/5 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Template - 17 ga/4 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Template - 17 ga/4 Fr — KOBOLD, LLC
- Kobold® Prostate HDR Template - 18 ga — KOBOLD, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kobold, Llc
Sources (1)
- FDA UDI 4d4d27b1-e8ed-4831-b767-38bebc66f72f 34 fields · synced May 30, 2026